Principal Research Scientist I, DMPK Senior Biologics Project Representative (On-site)
AbbVie
- Worcester, MA
- Permanent
- Full-time
- Serve as a QTAS representative on project teams supporting the development of novel biologics; collaborate with project team members (e.g., clinical pharmacology, protein analytics, discovery, toxicology) and groups within QTAS to generate relevant data guiding target validation, biomarker selection, and candidate selection
- Develop and drive the QTAS and PK/PD strategy for large molecule discovery, preclinical, and clinical development projects to support decisions and milestone transitions
- Effectively communicate QTAS and PK/PD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions.
- Demonstrate thorough understanding of the PK/PD and bioanalytical aspects necessary for the selection and characterization of antibodies, including considerations for bispecific antibodies, antibody-drug conjugates, and novel modalities
- Coordinate and request PK, PK/PD, and bioanalytical studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times
- Conduct value-added PK/PD-related quantitative analyses to support project team or project strategy decision-making
- Serve as a liaison with bioanalytical groups to ensure timely reagent generation, method development and sample analysis
- Prepare QTAS sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure generation of appropriate reports
- Bachelor with extensive experience (14+ years), Masters with substantial experience (12+ years), or Doctorate (Ph.D.) with at least 6 years of experience in the pharmaceutical or biotechnology industries
- Experience independently representing QTAS on biologics project teams is required (expertise with novel modalities is preferred)
- Expertise with PK analysis of biologics and relevant data analysis software such as Phoenix/WinNonlin is required
- Familiarity with modeling software such as MATLAB/SimBiology, R, Python, or Berkeley Madonna is desired
- Understanding of biologics PK/PD modeling and analytical assays for measuring biologic molecules and biomarkers (including ligand binding and mass spectrometry assays) in preclinical study samples is desired
- Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome
- Recognized expert in his/her discipline
- Demonstrated publication or patent record; lead/senior author contributions a plus
- Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment
- Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver
- High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills
- Passion for data analysis, solving technical problems and applying new technologies to further scientific goals
- Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
- Learns fast and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages innovation to reality